X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 030 04 11 000
Date submitted: 4/9/2011
Manufacturer:Triad Group
Device Type:Con-Zellin Alcohol Swabs
Description:Disinfecting Swab
Medical Device Identifier:Disinfecting Swab Con-Zellin included in Individual test Packs of Optimal IT (Cat No: 710024) and IT Leish (Cat no: 710124). Lots Starting With 7,8,9 & 0 included Lot Nos: OD0013M, OE0017M & OJ0025M.
Reason of Field Safety Corrective Action:Bacterial Contamination of Con-Zellin Alcohol Swabs Lots Starting With 7,8,9 & 0 included in Individual test Packs of Optimal IT (Cat No: 710024) Lot Nos: OD0013M, OE0017M & OJ0025M.
Remedy Action:CON-ZELLIN Alcohol Swabs which are included in Individual Pack of Optimal-IT should not be used anymore and must be replaced by Sterile Alcohol Swabs. Kindly forward this product information to all the users in your area.
Athorized Representative/Importer/Distributor:Al Nahir Trading Co, Riyadh (01) 4770444
Report Source:NCMDR
Source Ref. Number:21CA0AE97B259
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Manufacturer letter.pdf